생물학적 안전성 시험 제품 및 서비스 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 용도별, 시험 유형별, 지역별, 부문 예측(2025-2033년)

Biological Safety Testing Products And Services Market Growth & Trends:

The global biological safety testing products and services market size is expected to reach USD 12.09 billion by 2033, registering a CAGR of 10.64% from 2025 to 2033, according to a new report by Grand View Research, Inc. The market is predominantly driven by the increasing production of biologics, boosting the demand for highly effective biological safety testing tools. The increasing disease burden is expected to be a major factor responsible for the rising production of biologics, thereby propelling the market growth.

The increasing prevalence of chronic diseases associated with lifestyle, including diabetes and cancer, is a key factor contributing to the rise in drug development and subsequent commercialization. This is expected to increase the need for ensuring & scrutinizing the safety of specialized and targeted therapies, evaluating outcomes, and circumventing probable shortcomings. In addition, biotechnology and pharmaceutical companies are increasingly integrating biological safety testing products and services to produce contamination-free and highly potent biologics to cater to the large number of people suffering from target diseases. Safety testing for viral conditions is proving to be one of the primary concerns of most companies as it is a critical component of manufacturing, chemistry, and control of biologics. This is fueling growth opportunities in the market.

Laboratory-based contamination is leading to the development and refinement of workstations by incorporating biological safety products and services. The increasing need to work with tissue cultures, maintain the sterility of cell lines, and minimize cross-contamination has increased concerns regarding product integrity. Rising involvement by government healthcare organizations for implementing good manufacturing practices and subsequent testing & control at every production stage is expected to widen the scope for growth.

Furthermore, key players operating in the biological safety testing product & services market are constantly focusing on developing novel products and technologies, further expanding their product portfolio, and to meet the rising demand for biological safety testing globally. For instance, in December 2022, -Charles River Laboratories International, Inc. announced the launch of Endosafe Nexus 200, a fully robotic instrument capable of processing both complex or undiluted, serial dilutions for water, in-process, and final product testing, further expanding its endotoxin testing portfolio. The incorporation of automation through robotics has enabled streamlining the quality control process and subsequently improving overall process efficiency.

Biological Safety Testing Products And Services Market Report Highlights:

• Based on product, the reagents and kits segment held a leading revenue share of over 39.69% in 2024, due to their extensive use in research and clinical laboratories
• Based on application, the vaccines & therapeutics segment dominated in terms of market share in 2024 and is anticipated to grow at fastest growth rate owing to the increase in disease outbreaks over the years
• Based on test type, the endotoxin tests segment dominated in terms of the market share of in 2024, owing to the rising prevalence of bacterial infections
• North America dominated the overall market with a revenue share of 36.59% in 2024, owing to rising research investments in biotechnology and the growing burden of chronic diseases. This anticipates increasing the demand for molecular cytogenetics in the region over the forecast period
• Asia Pacific is anticipated to grow at the fastest growth rate over the forecast period due to growing healthcare spending and the development of healthcare infrastructure in developing countries like India and China

Table of Contents

Chapter 1. Biological Safety Testing Products & Services Market: Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Product Segment
    • 1.1.1.2. Application Segment
    • 1.1.1.3. Test Type segment
• 1.2. Regional Scope
• 1.3. Estimates and Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective - 1
  • 1.4.2. Objective - 2
  • 1.4.3. Objective - 3
• 1.5. Research Methodology
• 1.6. Information Procurement
  • 1.6.1. Purchased Database
  • 1.6.2. GVR's Internal Database
  • 1.6.3. Secondary Sources
  • 1.6.4. Primary Research
• 1.7. Information or Data Analysis
  • 1.7.1. Data Analysis Models
• 1.8. Market Formulation & Validation
• 1.9. Model Details
  • 1.9.1. Commodity Flow Analysis
• 1.10. List of Secondary Sources
• 1.11. List of Abbreviations

Chapter 2. Biological Safety Testing Products & Services Market: Executive Summary

• 2.1. Market Snapshot
• 2.2. Product and Application Snapshot
• 2.3. Test Type Snapshot
• 2.4. Competitive Landscape Snapshot

Chapter 3. Biological Safety Testing Products & Services Market Variables, Trends, & Scope

• 3.1. Market Segmentation and Scope
• 3.2. Market Lineage Outlook
  • 3.2.1. Parent Market Outlook
  • 3.2.2. Related/Ancillary Market Outlook
• 3.3. Market Dynamics
• 3.4. Market Drivers Analysis
  • 3.4.1. Increasing number of government initiatives and recommendations
  • 3.4.2. Increasing production of new biologics due to high disease burden
  • 3.4.3. High R&D investments in clinical research and life sciences research
• 3.5. Market Restraint Analysis
  • 3.5.1. Time-consuming approval process
• 3.6. Porter's Five Forces Analysis
• 3.7. PESTLE Analysis
• 3.8. Pipeline Analysis

Chapter 4. Biological Safety Testing Products & Services Market: Product Estimates & Trend Analysis

• 4.1. Biological Safety Testing Products & Services Market: Product Movement Analysis
• 4.2. Reagents & Kits
  • 4.2.1. Reagents & Kits Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.3. Services
  • 4.3.1. Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.4. Instruments
  • 4.4.1. Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Biological Safety Testing Products & Services Market: Application Estimates & Trend Analysis

• 5.1. Biological Safety Testing Products & Services Market: Application Movement Analysis
• 5.2. Vaccines & Therapeutics
  • 5.2.1. Vaccines & Therapeutics Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.2.2. Vaccines
    • 5.2.2.1. Vaccines Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.2.3. Monoclonal Antibodies
    • 5.2.3.1. Monoclonal Antibodies Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.2.4. Recombinant Protein
    • 5.2.4.1. Recombinant Protein Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.3. Blood & Blood-based Products
  • 5.3.1. Blood & Blood-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.4. Gene Therapy
  • 5.4.1. Gene Therapy Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Tissue & Tissue-based Products
  • 5.5.1. Tissue & Tissue-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Stem Cells
  • 5.6.1. Stem Cells Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Biological Safety Testing Products & Services Market: Test Type Estimates & Trend Analysis

• 6.1. Biological Safety Testing Products & Services Market: Test Type Movement Analysis
• 6.2. Endotoxin Tests
  • 6.2.1. Endotoxin Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.3. Sterility Tests
  • 6.3.1. Sterility Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.4. Cell Line Authentication & Characterization Tests
  • 6.4.1. Cell Line Authentication & Characterization Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Bioburden Tests
  • 6.5.1. Bioburden Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Adventitious Agent Detection Tests
  • 6.6.1. Adventitious Agent Detection Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Residual Host Contamination Detection Tests
  • 6.7.1. Residual Host Contamination Detection Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Others
  • 6.8.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Biological Safety Testing Products & Services Market: Regional Business Analysis

• 7.1. Regional Market Snapshot
• 7.2. North America
  • 7.2.1. North America Biological Safety Testing Products & Services Market Estimates And Forecast, 2021 - 2033 (USD Million)
  • 7.2.2. U.S.
    • 7.2.2.1. U.S. Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.2.2.2. Key Country Dynamics
    • 7.2.2.3. Regulatory Framework
    • 7.2.2.4. Reimbursement Scenario
    • 7.2.2.5. Competitive Scenario
  • 7.2.3. Canada
    • 7.2.3.1. Canada Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.2.3.2. Key Country Dynamics
    • 7.2.3.3. Regulatory Framework
    • 7.2.3.4. Reimbursement Scenario
    • 7.2.3.5. Competitive Scenario
  • 7.2.4. Mexico
    • 7.2.4.1. Mexico Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.2.4.2. Key Country Dynamics
    • 7.2.4.3. Regulatory Framework
    • 7.2.4.4. Reimbursement Scenario
    • 7.2.4.5. Competitive Scenario
• 7.3. Europe
  • 7.3.1. Europe Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.3.2. UK
    • 7.3.2.1. UK Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.2.2. Key Country Dynamics
    • 7.3.2.3. Regulatory Framework
    • 7.3.2.4. Reimbursement Scenario
    • 7.3.2.5. Competitive Scenario
  • 7.3.3. Germnay
    • 7.3.3.1. Germany Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.3.2. Key Country Dynamics
    • 7.3.3.3. Regulatory Framework
    • 7.3.3.4. Reimbursement Scenario
    • 7.3.3.5. Competitive Scenario
  • 7.3.4. Spain
    • 7.3.4.1. Spain Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.4.2. Key Country Dynamics
    • 7.3.4.3. Regulatory Framework
    • 7.3.4.4. Reimbursement Scenario
    • 7.3.4.5. Competitive Scenario
  • 7.3.5. France
    • 7.3.5.1. France Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.5.2. Key Country Dynamics
    • 7.3.5.3. Regulatory Framework
    • 7.3.5.4. Reimbursement Scenario
    • 7.3.5.5. Competitive Scenario
  • 7.3.6. Italy
    • 7.3.6.1. Italy Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.6.2. Key Country Dynamics
    • 7.3.6.3. Regulatory Framework
    • 7.3.6.4. Reimbursement Scenario
    • 7.3.6.5. Competitive Scenario
  • 7.3.7. Denmark
    • 7.3.7.1. Denmark Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.7.2. Key Country Dynamics
    • 7.3.7.3. Regulatory Framework
    • 7.3.7.4. Reimbursement Scenario
    • 7.3.7.5. Competitive Scenario
  • 7.3.8. Sweden
    • 7.3.8.1. Sweden Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.8.2. Key Country Dynamics
    • 7.3.8.3. Regulatory Framework
    • 7.3.8.4. Reimbursement Scenario
    • 7.3.8.5. Competitive Scenario
  • 7.3.9. Norway
    • 7.3.9.1. Norway Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.9.2. Key Country Dynamics
    • 7.3.9.3. Regulatory Framework
    • 7.3.9.4. Reimbursement Scenario
    • 7.3.9.5. Competitive Scenario
• 7.4. Asia Pacific
  • 7.4.1. Asia Pacific Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.4.2. Japan
    • 7.4.2.1. Japan Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.2.2. Key Country Dynamics
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Scenario
    • 7.4.2.5. Competitive Scenario
  • 7.4.3. China
    • 7.4.3.1. China Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.3.2. Key Country Dynamics
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Scenario
    • 7.4.3.5. Competitive Scenario
  • 7.4.4. India
    • 7.4.4.1. India Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.4.2. Key Country Dynamics
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Scenario
    • 7.4.4.5. Competitive Scenario
  • 7.4.5. South Korea
    • 7.4.5.1. South Korea Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.5.2. Key Country Dynamics
    • 7.4.5.3. Regulatory Framework
    • 7.4.5.4. Reimbursement Scenario
    • 7.4.5.5. Competitive Scenario
  • 7.4.6. Thailand
    • 7.4.6.1. Thailand Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.6.2. Key Country Dynamics
    • 7.4.6.3. Regulatory Framework
    • 7.4.6.4. Reimbursement Scenario
    • 7.4.6.5. Competitive Scenario
  • 7.4.7. Australia
    • 7.4.7.1. Australia Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.7.2. Key Country Dynamics
    • 7.4.7.3. Regulatory Framework
    • 7.4.7.4. Reimbursement Scenario
    • 7.4.7.5. Competitive Scenario
• 7.5. Latin America
  • 7.5.1. Latin America Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.5.2. Brazil
    • 7.5.2.1. Brazil Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.5.2.2. Key Country Dynamics
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Scenario
    • 7.5.2.5. Competitive Scenario
  • 7.5.3. Argentina
    • 7.5.3.1. Argentina Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.5.3.2. Key Country Dynamics
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Scenario
    • 7.5.3.5. Competitive Scenario
• 7.6. MEA
  • 7.6.1. MEA Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.6.2. South Africa
    • 7.6.2.1. South Africa Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.2.2. Key Country Dynamics
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Scenario
    • 7.6.2.5. Competitive Scenario
  • 7.6.3. Saudi Arabia
    • 7.6.3.1. Saudi Arabia Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.3.2. Key Country Dynamics
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Scenario
    • 7.6.3.5. Competitive Scenario
  • 7.6.4. UAE
    • 7.6.4.1. UAE Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.4.2. Key Country Dynamics
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Scenario
    • 7.6.4.5. Competitive Scenario
  • 7.6.5. Kuwait
    • 7.6.5.1. Kuwait Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.5.2. Key Country Dynamics
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Scenario
    • 7.6.5.5. Competitive Scenario

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Strategy Mapping
  • 8.2.1. New Product Launch
  • 8.2.2. Partnerships
  • 8.2.3. Acquisition
  • 8.2.4. Collaboaration
  • 8.2.5. Funding
• 8.3. Key Company Market Share Analysis, 2022
• 8.4. Company Heat Map Analysis
• 8.5. Company Profiles
  • 8.5.1. Charles River Laboratories
    • 8.5.1.1. Company Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. BSL Bioservice
    • 8.5.2.1. Company Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. Lonza
    • 8.5.3.1. Company Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. Merck KGaA (MilliporeSigma)
    • 8.5.4.1. Company Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Samsung Biologics
    • 8.5.5.1. Company Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. Sartorius AG
    • 8.5.6.1. Company Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. Eurofins Scientific
    • 8.5.7.1. Company Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. SGS Societe Generale de Surveillance SA
    • 8.5.8.1. Company Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. Thermo Fisher Scientific Inc.
    • 8.5.9.1. Company Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. BIOMERIEUX
    • 8.5.10.1. Company Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives